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STERILE DOPAMINE CONCENTRATE BP 200MG/ 5ML

Active substance(s): DOPAMINE HYDROCHLORIDE

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Package leaflet: information for the user

Sterile Dopamine Concentrate BP
200mg/5ml and 800mg/5ml
Dopamine Hydrochloride

C9131700000

Read all of this leaflet carefully before you use Dopamine
Concentrate.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or
nurse.
• If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
nurse.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Dopamine Concentrate is and what it is used for
Before you are given Dopamine Concentrate
How Dopamine Concentrate is given
Possible side effects
Storing Dopamine Concentrate
Further information

1. What Dopamine Concentrate is and what it
is used for
Dopamine hydrochloride is one of a group of medicines that
stimulate the heart and acts on blood vessels and the kidneys.
Dopamine Concentrate is used in the treatment of diseases of the
heart muscle, kidney failure and poor blood flow. It is also used
in the treatment of shock associated with heart attacks, trauma
(injury), blood poisoning, open heart surgery and heart failure.

2. Before you are given Dopamine Concentrate
You should not be given Dopamine Concentrate if:
• you are allergic to Dopamine Hydrochloride or any of
ingredients listed in section 6 of this leaflet
• you have a tumour in the adrenal glands known as
phaeochromocytoma
• you have a fast and irregular heartbeat
Take special care with Dopamine Concentrate if:
• you are pregnant or breast-feeding.
If any of the above applies to you, please consult your doctor
before you are given Dopamine Concentrate.
Taking with other medicines
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines, including those obtained without
prescription.
Medicines that may interact with Dopamine Concentrate include:
• medicines used to treat depression such as amitriptyline
• phenytoin, a medicine used to treat fits
• dopexamine, a medicine used to increase blood flow
• ergotamine, a medicine used to treat headaches
• guanethidine, a medicine used to treat high blood pressure
• adrenergic blocking agents such as doxazosin
• Monoamine-Oxidase Inhibitors (MAOI), a type of medicine
used to treat depression
• certain anaesthetics, such as halothane
• entacapone, a medicine used in Parkinson’s disease
• doxapram, used as a respiratory stimulant.
If you have any doubts about whether this medicine should
be administered to you, consult your doctor or nurse.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant
or are breast-feeding before you are given this medicine.
Effects on the ability to drive and use machinery
There are no reported effects of Dopamine Concentrate on
driving and using machinery.
Important information about some of the ingredients of this
medicine
This medicine contains sodium metabisulphite which in rare
cases may cause an allergic reaction, the symptoms of which
include difficulty breathing, a red itchy rash and facial swelling. If
you experience any of these side effects please tell your doctor or
nurse immediately.

3. How Dopamine Concentrate is given
Your doctor will determine the dose you require and dilute the
Dopamine Concentrate with a sterile solution. The doctor will
then give the dopamine solution by intravenous infusion via a
drip into as large a vein as possible.
Adults including the elderly
The rate of administration will be carefully controlled and
adjusted according to your response. The dose will be gradually
increased until the optimum dosage is achieved. During
treatment your heart rate, blood pressure and urine output will
be measured to check how you are responding.
Children
Use in children is not recommended.
If you are given too much Dopamine Concentrate
If you are at all concerned that you have been given too much of
this medicine please tell your doctor immediately.

4. Possible side effects
Like all medicines, Dopamine Concentrate can cause side effects,
although not everybody gets them.
One of the ingredients of this medicine may cause an allergic
reaction (see section 2 of this leaflet ‘Important information
about some of the ingredients of this medicine’). Tell your doctor
or nurse immediately if you experience any of the following
symptoms:
• swelling of the face, lips or tongue
• wheezing or difficulty breathing
• rashes, red, raised lumps or itching
Other rare side effects include:
• body hair standing on end
• kidney problems
• high blood pressure.
Common side effects include:
• changes in the heartbeat
• chest pains
• breathing difficulties
• feeling sick (nausea)
• being sick (vomiting)
• fall in blood pressure
• narrowing of blood vessels.

Regulatory Affairs / OL customer
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If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.

5. Storing Dopamine Concentrate
Keep out of the reach and sight of children.
This product has an expiry date on the ampoule label. The doctor
or nurse will check that the product has not passed this date. The
expiry date refers to the last day of that month.
Do not use if the contents are discoloured.
This product must be protected from light.
It should not be stored above 25°C.

6. Further Information
What Dopamine Concentrate contains
The active ingredient is dopamine hydrochloride
the other ingredients are sodium metabisulphite, water for
injections, hydrochloric acid and potassium hydroxide.
What Dopamine Concentrate looks like and the contents of
the pack.
The injection is supplied in glass ampoules, each containing 5ml.
The ampoules are supplied in packs of 10 ampoules.
Marketing Authorisation Holder and Manufacturer
Martindale Pharmaceuticals Ltd.,
Bampton Road,
Harold Hill,
Romford Essex RM3 8UG
Product licence numbers: PL 0156/0087

PL 0156/0088
Sterile Dopamine Concentrate BP 200mg/5ml and 800mg/5ml
Date of last revision: May 2008

C9131700000

100mm Measurement Verification Bar

ORACLE code: C91317
Description: PIL Dopamine 200mg and 800mg
Market: UK
PCI: 0404
Replaces code: C91223
Template/style number: 170 x 296mm
Colours: PMS Black PMS
PMS PMS
Min Point size (legal text): 8pt
Version number: 01 Date: 27/04/12 By: AC
Date of previous revision: 25/04/12 (D02040-D)
EAN Barcode (if applicable):
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prior to circulation
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Quality
Accept 3 Reject 7
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Software/platform: InDesign CS5
Linked graphics:
Fonts: Myriad Pro
File name: C91317-01
Component specifics:
Nominal Dimensions: 170 x 296mm
Grand Fromage Creative Limited
Amherst House, 22 London Road
Riverhead, Sevenoaks, Kent, TN13 2BT, UK
t: 01732 456 187
e: alan@grand-fromage.co.uk www.grand-fromage.co.uk

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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